An interventional study of Virtual Reality-Based Hypnotherapy and Conventional Physiotherapy in Spinal Cord Injuries (SCI), Chronic Pain and Neuropathic Pain, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether virtual reality (VR)-based hypnotherapy, added to conventional physiotherapy, improves pain, sleep, mood, and quality of life in adults with chronic spinal cord injury.
The main questions it aims to answer are:
Researchers will compare participants who receive VR-based hypnotherapy in addition to physiotherapy with participants who receive physiotherapy alone.
Participants will:
Background and Rationale Pain is one of the most common and disabling consequences of spinal cord injury (SCI) and negatively affects functional status, sleep, emotional well-being, and quality of life. Pharmacological treatments are often insufficient or limited by side effects, and there is a need for safe, non-invasive, non-pharmacological adjunct therapies. Virtual reality (VR) may reduce pain through attentional redirection and immersion, while hypnotherapy may modulate pain perception through relaxation and cognitive reprocessing of pain. VR-based hypnotherapy combines these mechanisms and has shown short-term benefits in chronic musculoskeletal pain; however, its effects in individuals with SCI have not been investigated in a randomized controlled trial.
Study Design This is a prospective, randomized controlled, parallel-group, single-center, single-blind trial. A total of 40 patients with SCI will be enrolled. Participants will be allocated to two groups by computer-generated randomization: (1) intervention group, receiving VR-based hypnotherapy in addition to conventional physiotherapy; (2) control group, receiving conventional physiotherapy alone.
Interventions Both groups will receive a standard physiotherapy and rehabilitation program, 5 days per week for 2 weeks (10 sessions in total). Participants in the intervention group will additionally receive an approximately 20-minute VR-based hypnotherapy session following each physiotherapy session. Sessions will be delivered in a quiet clinical setting using a VR headset and headphones. The number of sessions completed and session duration will be recorded for each participant.
Baseline Data Sociodemographic characteristics, injury etiology and duration, comorbidities, complications, and current analgesic and antispastic medication use will be recorded. Neurological level and severity of injury will be classified according to the American Spinal Injury Association (ASIA) Impairment Scale.
Blinding Outcome assessments will be performed by a trained assessor blinded to group allocation. Due to the nature of the intervention, participants and therapists cannot be blinded.
Assessment Time Points Assessments will be conducted at baseline (T0), at the end of the 2-week intervention (T1), and 2 weeks after the end of the intervention (T2).
Safety Adverse events, including VR-related symptoms such as dizziness or nausea, will be recorded throughout the intervention period.
Statistical Analysis Data will be analyzed using SPSS. Descriptive statistics will be presented as mean, standard deviation, frequency, and percentage. Normality will be assessed using the Kolmogorov-Smirnov test. Between-group comparisons will be performed using the independent samples t-test or the Mann-Whitney U test, as appropriate. Changes over time will be analyzed using appropriate repeated-measures analyses. Statistical significance will be set at p\<0.05.
Exclusion Criteria:
Participants will receive a standard physiotherapy and rehabilitation program 5 days per week for 2 weeks (10 sessions). In addition, following each physiotherapy session, they will receive an approximately 20-minute virtual reality (VR)-based hypnotherapy session delivered in a quiet clinical setting via a VR headset and headphones (10 VR sessions in total).
Behavioral: Virtual Reality-Based Hypnotherapy · Other: Conventional Physiotherapy
Participants will receive the same standard physiotherapy and rehabilitation program 5 days per week for 2 weeks (10 sessions), without VR-based hypnotherapy.
Other: Conventional Physiotherapy
An immersive, audio-guided hypnotherapy session delivered through a virtual reality headset and headphones, combining visual immersion with hypnotic induction, relaxation, and pain-modulating suggestions. Each session lasts approximately 20 minutes and is administered immediately after the physiotherapy session, 5 days per week for 2 weeks (10 sessions in total), in a quiet clinical setting.
Also known as: VR Hypnosis, VR-Mediated Hypnotherapy
A standard physiotherapy and rehabilitation program for spinal cord injury, applied 5 days per week for 2 weeks (10 sessions in total), identical in both study arms.
Change in Pain Intensity (Numeric Rating Scale)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. The change from baseline to the end of the intervention will be compared between groups.
Time frame: Baseline and end of the 2-week intervention (week 2)
Pain Intensity at Follow-up (Numeric Rating Scale)
Pain intensity will be assessed using the NRS (0-10). Higher scores indicate greater pain intensity. The persistence of the effect will be evaluated at follow-up.
Time frame: Baseline and 2 weeks after the end of the intervention (week 4)
Neuropathic Pain (DN4 Questionnaire)
Neuropathic pain will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire, with total scores ranging from 0 to 10. Higher scores indicate a greater likelihood and burden of neuropathic pain features.
Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)
Sleep Quality (Pittsburgh Sleep Quality Index)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with global scores ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)
Anxiety (Hospital Anxiety and Depression Scale - Anxiety Subscale)
Anxiety will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), with scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms.
Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)
Depression (Hospital Anxiety and Depression Scale - Depression Subscale)
Depression will be assessed using the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D), with scores ranging from 0 to 21. Higher scores indicate more severe depressive symptoms.
Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)
Spasticity (Modified Ashworth Scale)
Spasticity will be assessed using the Modified Ashworth Scale (MAS), graded as 0, 1, 1+, 2, 3, and 4. Higher grades indicate greater muscle tone.
Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)
Health-Related Quality of Life (EQ-5D-5L)
Health-related quality of life will be assessed using the EQ-5D-5L, including the five-dimension index score and the EQ Visual Analogue Scale (EQ-VAS, 0-100). Higher index and EQ-VAS scores indicate better health status.
Time frame: Baseline, week 2 (end of intervention), and week 4 (follow-up)
System Usability (System Usability Scale)
Usability of the VR-based hypnotherapy system will be assessed in the intervention group only using the System Usability Scale (SUS), with scores ranging from 0 to 100. Higher scores indicate better usability.
Time frame: End of the 2-week intervention (week 2)
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication will be shared upon reasonable request to the principal investigator.
Supporting information: Study protocol
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Istanbul Physical Medicine Rehabilitation Training and Research Hospital